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eISF - Electronic Investigator Site File

Powered by Menka AI

A site file that 
reduces admin.
Not just digitises it.

Menka AI handles tagging documents, log entries, signature workflows, and task routing automatically — so sites spend less time managing documents and more time on the study.

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Site teams are under pressure.

As a result, the ISF is often an overlooked item.

Missing log signatures, outdated CVs, training records that don't match the delegation log. When teams are stretched, documenka-aition slips. Menka AI is there to close that gap — automating the parts of site documenka-aition that should never be manual in the first place.

Digital Logs for Every Workflow

Replace paper and Excel with a single controlled digital source.

All key study logs — delegation, training, screening, visits, deviations, and more — captured directly in the platform.

(BYOT) Bring Your Own Templates. We easily configure them into the platform. Your team can focus on their work — with Menka AI providing continuous digital control and inspection readiness.

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Automated Task Routing

Menka AI helps every team member know exactly what to do.

Pending tasks appear automatically for each user — signature requests, document reviews, log updates — with a direct link to the exact document that needs action.

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Expiry and Signature Control

CVs, certificates, and signatures. Monitored automatically.

Menka AI tracks expiry dates on CVs, GCP certificates, and other documents against your study rules. Reminders go out automatically. Missing signatures are flagged immediately.

Nothing reaches a reviewer without Menka AI's supporting checks being completed first.

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Connected to Sponsor eTMF

The site files. The sponsor sees it. No email, no manual sharing.

Menken eISF and eTMF share the same platform. What gets filed at site level flows into the sponsor's TMF automatically — with the right permissions, the right metadata, the right structure.

Menka AI — built into eTMF

Ask Menka AI anything
about your TMF.

Menka AI understands your site file as well as you do. Ask in plain language. Get a direct answer.

No digging through folders. No manual status reports. Just ask.

"Is the delegation log complete?"

Menka AI checks every entry and tells you exactly what's missing.

"Which signatures are still pending?"

Menka AI shows the list, who needs to sign, and has already sent reminders.

"Are any CVs expiring this quarter?"

Menka AI tracks every expiry date and flags them before they become findings.

We believe in a human-in-the-loop model — you can always review Menka AI's checks to make sure nothing slips by.

Our commitment

We guarantee compliance. Full stop.

Every client using Menken Trials has zero inspection findings related to our platform. Menka AI makes that possible — catching everything, leaving nothing to find.

0 findings

Inspection findings related to our platform — across every client, every study, ever

500+ AI checks

Real-time compliance checks running on every document, log, and milestone

24/7 always on

Menka AI monitors your site file around the clock, every day of your trial

A very flexible and user-friendly database that the developers easily adapt to project needs. You're not just buying a product — you're getting reliable technical support. We highly recommend their solution without hesitation.

Andrus Aavik

Head of Diagnostic Clinic, Viljandi Hospital

Frequently asked questions.

Does PII stay at the site?

Yes. Patient identifiable information is stored and processed at site level. Sponsors receive the documents they need without accessing raw PII. The subject identification log never leaves the site.

Can sites use their existing templates? (BYOT)

Yes — (BYOT) Bring Your Own Templates. We easily configure your existing log formats into the platform. Nothing changes about how your team works.

Does eISF connect to the sponsor's eTMF automatically?

Yes. Documents filed at site level flow into the sponsor's TMF with the correct metadata and structure — no manual export required. Only permitted documents are shared.

Can auditors or inspectors be given access?

Yes. Auditors and inspectors can be given read-only access to the specific documents or sections they are permitted to see, managed through the TMF matrix.

What log types does the eISF support?

All key study logs: Delegation, Training, Screening, Site Visit, Protocol Deviations, Subject Expenses, and more. Custom formats supported through configuration.

How long does setup take?

From agreed configuration to a live study is typically less than one day. Team training takes under one hour on average.

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See what a site file looks like
when it actually works.

Book a short call. We'll walk through your site file with a real study example, show you how Menka AI works, and what she would catch.

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